Search Results

Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the STERRAD® 100, STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles), STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles), AMSCO® V-PRO® 1 (Lumen cycle), AMSCO® V-PRO® 1 Plus (Lumen and Non Lumen cycles), AMSCO® V-PRO® maX, Low Temperature Sterilization System (Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles), and AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen and Flexible, and Fast Non Lumen cycles) sterilizers. The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.

The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 consists of a noncellulosic plastic backing material with a pressure-sensitive adhesive on one side and chemical indicator stripes on the other side. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.

The device is the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228, a chemical indicator used to determine if items have been processed in specific hydrogen peroxide sterilization systems.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes for each test in Table 6.1. It describes the "Purpose" as demonstrating performance in specific sterilizers and cycles. The provenance of the data is not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is a chemical indicator, not an AI/medical imaging device. Therefore, the concept of "experts" establishing ground truth in the context of human interpretation of data (like radiologists for imaging) is not directly applicable. The "ground truth" for chemical indicators is determined by their physical and chemical response to specific sterilization conditions. The testing would be performed by qualified laboratory personnel following established protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a chemical indicator. Adjudication methods are typically relevant for subjective interpretations, often in medical image analysis. The performance of a chemical indicator is based on observable color changes under controlled conditions.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device or an imaging product that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical chemical indicator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for chemical indicators is the physical/chemical response of the indicator to controlled sterilization parameters (e.g., exposure to a specified concentration of hydrogen peroxide for a given time and temperature, resulting in a color change). The sterilization process itself, as defined by the sterilizer's validated cycles, serves as the "gold standard" or ground truth for whether sterilization conditions were met. The indicator is designed to react to these conditions.

8. The sample size for the training set

Not applicable. This product is a physical chemical indicator and does not involve AI or machine learning models that require a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set is used for this type of device.

Ask a specific question about this device